CLINICAL TRIALS PROFILE FOR BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

All Clinical Trials for budesonide; formoterol fumarate dihydrate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00569712 ↗	Studying Genes in Blood and Lung Fluid Samples From Patients With Chronic Obstructive Pulmonary Disease With or Without a Previous Diagnosis of Lung Cancer or With Asthma Treated With Budesonide and Formoterol	Completed	Astra Zeneca Canada	Phase 1	2007-01-01	RATIONALE: Studying the genes expressed in samples of blood and lung fluid in the laboratory from patients receiving budesonide and formoterol may help doctors learn more about the effect of budesonide and formoterol on gene expression and biomarkers. PURPOSE: This clinical trial is studying genes in blood and lung fluid samples from patients with chronic obstructive pulmonary disease, with or without a previous diagnosis of lung cancer, or with asthma treated with budesonide and formoterol.
NCT00569712 ↗	Studying Genes in Blood and Lung Fluid Samples From Patients With Chronic Obstructive Pulmonary Disease With or Without a Previous Diagnosis of Lung Cancer or With Asthma Treated With Budesonide and Formoterol	Completed	AstraZeneca	Phase 1	2007-01-01	RATIONALE: Studying the genes expressed in samples of blood and lung fluid in the laboratory from patients receiving budesonide and formoterol may help doctors learn more about the effect of budesonide and formoterol on gene expression and biomarkers. PURPOSE: This clinical trial is studying genes in blood and lung fluid samples from patients with chronic obstructive pulmonary disease, with or without a previous diagnosis of lung cancer, or with asthma treated with budesonide and formoterol.
NCT00569712 ↗	Studying Genes in Blood and Lung Fluid Samples From Patients With Chronic Obstructive Pulmonary Disease With or Without a Previous Diagnosis of Lung Cancer or With Asthma Treated With Budesonide and Formoterol	Completed	British Columbia Cancer Agency	Phase 1	2007-01-01	RATIONALE: Studying the genes expressed in samples of blood and lung fluid in the laboratory from patients receiving budesonide and formoterol may help doctors learn more about the effect of budesonide and formoterol on gene expression and biomarkers. PURPOSE: This clinical trial is studying genes in blood and lung fluid samples from patients with chronic obstructive pulmonary disease, with or without a previous diagnosis of lung cancer, or with asthma treated with budesonide and formoterol.
NCT00964535 ↗	Bioequivalence Study of Budesonide/Formoterol Easyhaler and Symbicort Turbohaler in Asthmatics	Completed	Orion Corporation, Orion Pharma	Phase 1/Phase 2	2009-09-01	The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbohaler in terms of the drug absorbed into the bloodstream.
NCT01386996 ↗	Comparison of Budesonide and Formoterol Absorption From Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler	Completed	Orion Corporation, Orion Pharma	Phase 1	2011-07-01	The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.

Clinical Trial Conditions for budesonide; formoterol fumarate dihydrate

Condition Name

Condition Name for budesonide; formoterol fumarate dihydrate
Intervention	Trials
Asthma	9
Bioequivalence	1
Chronic Obstructive Lung Disease	1
Chronic Obstructive Pulmonary Disease (COPD)	1

Condition MeSH

Condition MeSH for budesonide; formoterol fumarate dihydrate
Intervention	Trials
Asthma	4
Pulmonary Disease, Chronic Obstructive	3
Lung Diseases	2
Lung Diseases, Obstructive	2

Clinical Trial Locations for budesonide; formoterol fumarate dihydrate

Trials by Country

Trials by Country for budesonide; formoterol fumarate dihydrate
Location	Trials
United States	44
Finland	3
United Kingdom	2
Denmark	1
Hungary	1

Trials by US State

Trials by US State for budesonide; formoterol fumarate dihydrate
Location	Trials
Ohio	2
Nebraska	2
Montana	2
Florida	2
Colorado	2

Clinical Trial Progress for budesonide; formoterol fumarate dihydrate

Clinical Trial Phase

Clinical Trial Phase for budesonide; formoterol fumarate dihydrate
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	4
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for budesonide; formoterol fumarate dihydrate
Clinical Trial Phase	Trials
Completed	9
Not yet recruiting	1
Terminated	1

Clinical Trial Sponsors for budesonide; formoterol fumarate dihydrate

Sponsor Name

Sponsor Name for budesonide; formoterol fumarate dihydrate
Sponsor	Trials
Orion Corporation, Orion Pharma	3
Intech Biopharm Ltd.	2
AstraZeneca	2

Sponsor Type

Sponsor Type for budesonide; formoterol fumarate dihydrate
Sponsor	Trials
Industry	13
Other	3

Budesonide; formoterol fumarate dihydrate Market Analysis and Financial Projection

Budesonide and Formoterol Fumarate Dihydrate: Clinical Trials, Market Analysis, and Projections

Introduction

Budesonide and formoterol fumarate dihydrate, a combination of an inhaled corticosteroid (ICS) and a long-acting beta-agonist (LABA), are widely used in the treatment of asthma and chronic obstructive pulmonary disease (COPD). This article provides an update on the current clinical trials, market analysis, and future projections for this drug combination.

Clinical Trials Update

Ongoing and Recent Trials

Several clinical trials are currently underway or have recently been completed to evaluate the efficacy and safety of budesonide and formoterol fumarate dihydrate.

VATHOS Study

A 24-week efficacy and safety study, VATHOS, is assessing the use of budesonide and formoterol fumarate metered dose inhaler (MDI) in adult and adolescent participants with inadequately controlled asthma. This Phase 3 trial, sponsored by AstraZeneca, is recruiting participants and is expected to complete by December 2024[1].

LITHOS Study

The LITHOS study is a 12-week randomized, double-blind, parallel group, multicenter trial comparing the efficacy and safety of budesonide and formoterol fumarate MDI to budesonide MDI alone in participants with inadequately controlled asthma. This study aims to evaluate the benefits of the combination therapy over monotherapy[3].

ATHLOS Study

The ATHLOS study is investigating the effect of budesonide, glycopyrronium, and formoterol fumarate (BGF) MDI, budesonide and formoterol fumarate (BFF) MDI, and placebo MDI on exercise parameters in participants with COPD. This Phase 3 trial is also sponsored by AstraZeneca and is currently recruiting participants[1].

Key Findings

Previous studies, such as the ETHOS trial, have shown that the combination of budesonide, glycopyrronium, and formoterol fumarate (BGF) significantly reduces the rate of moderate to severe exacerbations in COPD patients compared to dual therapies like budesonide and formoterol fumarate (BFF) and glycopyrronium and formoterol fumarate (GFF)[1].

Market Analysis

Market Size and Growth

The global budesonide inhaler market, which includes budesonide and formoterol fumarate dihydrate, is expected to witness significant growth. In 2017, the market was valued at US$ 5.25 billion and is projected to exhibit a compound annual growth rate (CAGR) of 5.8% from 2018 to 2026, reaching US$ 8.24 billion by 2026[2].

As of 2023, the market was valued at US$ 6.8 billion and is estimated to grow at a CAGR of 6.6% from 2024 to 2034, reaching US$ 13.6 billion by 2034[5].

Regional Market

North America holds the largest share in the budesonide inhaler market, and this dominance is expected to continue during the forecast period. The Asia Pacific region is also anticipated to show significant growth due to the presence of major companies in emerging economies like China, India, and Japan[2][5].

Generic Versions and New Launches

The introduction of generic versions of budesonide inhalers has expanded the consumer base, especially in low- and middle-income economies. For instance, Viatris launched Breyna (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, the first generic version of AstraZeneca’s Symbicort, approved by the U.S. FDA for treating COPD and asthma[5].

Dosage Forms and Strengths

The market is segmented by dosage forms, including aerosols, dry powder, suspension, and spray. The aerosol form is particularly popular due to its ease of use and effectiveness. The market is also segmented by strength, with common strengths being 0.25 mg and 0.5 mg[5].

Projections and Future Outlook

Increasing Incidence of Asthma and COPD

The rising incidence of asthma and COPD globally is a key driver for the growth of the budesonide inhaler market. According to the Centers for Disease Control and Prevention (CDC), over 26 million people in the U.S. have asthma, regardless of age, gender, and race[2].

Development of New Drug Combinations

Companies are focused on developing new drug combinations, particularly for the pediatric population. For example, AstraZeneca’s Symbicort (budesonide/formoterol fumarate dihydrate) was approved by the U.S. FDA for the treatment of asthma in pediatric patients aged 6 to 12 years[2].

Over-the-Counter (OTC) Availability

There is a growing interest in making budesonide-formoterol available over-the-counter (OTC) for mild asthma, which could further boost preventive measures and market growth[5].

Key Takeaways

• Clinical Trials: Ongoing trials like VATHOS, LITHOS, and ATHLOS are evaluating the efficacy and safety of budesonide and formoterol fumarate dihydrate in asthma and COPD.
• Market Growth: The global budesonide inhaler market is projected to grow significantly, driven by increasing incidences of asthma and COPD and the introduction of generic versions.
• Regional Dominance: North America currently holds the largest market share, with the Asia Pacific region expected to show significant growth.
• New Launches: Generic versions and new drug combinations are expanding the market, with a focus on pediatric and OTC treatments.

FAQs

What are the current clinical trials for budesonide and formoterol fumarate dihydrate?

Current trials include the VATHOS study for inadequately controlled asthma, the LITHOS study comparing combination therapy to monotherapy, and the ATHLOS study evaluating exercise parameters in COPD patients.

How is the global budesonide inhaler market expected to grow?

The market is expected to grow at a CAGR of 6.6% from 2024 to 2034, reaching US$ 13.6 billion by 2034.

What regions are driving the growth of the budesonide inhaler market?

North America holds the largest share, but the Asia Pacific region is expected to show significant growth due to the presence of major companies in emerging economies.

What are the key drivers for the growth of the budesonide inhaler market?

The rising incidence of asthma and COPD, introduction of generic versions, and development of new drug combinations are key drivers.

Are there any new launches or approvals in the budesonide inhaler market?

Yes, recent launches include Viatris’s Breyna, the first generic version of AstraZeneca’s Symbicort, approved by the U.S. FDA.

What is the potential impact of making budesonide-formoterol available over-the-counter (OTC)?

Making budesonide-formoterol available OTC could boost preventive measures and further expand the market by making the treatment more accessible for mild asthma.

Sources

1. LARVOL Sigma: Budesonide/Formoterol (PT009) News.
2. GlobeNewswire: Global Budesonide Inhaler Market to Surpass US$ 8.24 Billion by 2026.
3. AstraZeneca Clinical Trials: A 12-week study to assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler.
4. AstraZeneca Clinical Trials: A Study to Evaluate the Effect of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Metered Dose Inhaler.
5. Transparency Market Research: Budesonide Inhaler Market Size, Share & Trends, Forecast - 2034.